EMA/PE/0000224110 - paediatric investigation plan

esketamine hydrochloride

Key facts

• Invented name:
  Spravato
• Active substance:
  esketamine hydrochloride
• Therapeutic area:
  Psychiatry
• Decision number:
  EMA/PE/0000224110
• PIP number:
  EMA/PE/0000224110
• Pharmaceutical form(s):
  Nasal spray (solution)
• Condition(s) / indication(s):
  Treatment of major depressive disorder
• Route(s) of administration:
  Intranasal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2025
• Compliance check done:
  Ne

Decision

P/0136/2022 : EMA decision of 13 April 2022 on the acceptance of a modification of an agreed paediatric investigation plan for esketamine (hydrochloride) (Spravato), (EMEA-001428-PIP03-15-M02)

Adopted Reference Number: EMA/157572/2022

EMA/PE/0000224110 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for esketamine (hydrochloride)

Adopted Reference Number: EMADOC-1700519818-1859738